The purpose of this research study is to compare the treatment device (Solyx) to a different mesh sling or control device (Obtryx II) for the treatment of symptoms for SUI. Safety information and patient outcomes will be collected for three (3) years and evaluated.

A Prospective, Non-Randomized, Parallel Cohort, Multi-center Study of the Solyx™ Single Incision Sling System vs. the Obtryx™ II Sling System for the Treatment of Women With Stress Urinary Incontinence

The primary endpoint is an assessment of improvement in stress urinary incontinence at 36 months as compared to Baseline, by a composite of objective and subjective measures. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

The primary endpoint is an assessment of improvement in stress urinary incontinence at 36 months as compared to Baseline, by a composite of objective and subjective measures: negative cough stress test and a subject self-reported improvement in their condition, through the Patient Global Impression of Improvement (PGI-I).

Subjects with known or suspected hypersensitivity to polypropylene mesh

Subjects with any of the following confounding conditions:

Neurogenic bladder

Urethral stricture and bladder neck contracture

Bladder stones or tumors

Urinary tract fistula or diverticula

Pathology which would compromise implant placement including subjects currently taking anticoagulation therapy

Pathology that would limit blood supply or infections that would compromise healing including chemotherapy, systemic steroids and systemic immunosuppressants

Subjects with diabetes and an A1c ≥ 7%

Non-English speaking subjects

Subjects who have participated in an investigational study (medical device or drug) within 30 days of study entry that may impact analysis of this device or have previously participated in the current study

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01784588